"The U.S. Food and Drug Administration today approved Dotarem (gadoterate meglumine) for use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older.
Dotarem is a gadolinium-based"...
TOBI® (tobramycin) was generally well tolerated during two clinical studies in 258 cystic fibrosis patients ranging in age from 6 to 48 years. Patients received TOBI® (tobramycin) in alternating periods of 28 days on and 28 days off drug in addition to their standard cystic fibrosis therapy for a total of 24 weeks.
Voice alteration and tinnitus were the only adverse experiences reported by significantly more TOBI® (tobramycin) -treated patients. Thirty-three patients (13%) treated with TOBI® (tobramycin) complained of voice alteration compared to 17 (7%) placebo patients. Voice alteration was more common in the on-drug periods.
Eight patients from the TOBI® (tobramycin) group (3%) reported tinnitus compared to no placebo patients. All episodes were transient, resolved without discontinuation of the TOBI® (tobramycin) treatment regimen, and were not associated with loss of hearing in audiograms. Tinnitus is one of the sentinel symptoms of cochlear toxicity, and patients with this symptom should be carefully monitored for high frequency hearing loss. The numbers of patients reporting vestibular adverse experiences such as dizziness were similar in the TOBI® (tobramycin) and placebo groups.
Nine (3%) patients in the TOBI® (tobramycin) group and nine (3%) patients in the placebo group had increases in serum creatinine of at least 50% over baseline. In all nine patients in the TOBI® (tobramycin) group, creatinine decreased at the next visit.
Table 1 lists the percent of patients with treatment-emergent adverse experiences (spontaneously reported and solicited) that occurred in > 5% of TOBI® (tobramycin) patients during the two Phase III studies.
Table 1: Percent of Patients With Treatment Emergent Adverse
Experiences Occurring in > 5% of TOBI® (tobramycin) Patients
|Adverse Event||TOBI® (tobramycin)
|Lung Function Decreased2||16.3||15.3|
|Lower Respiratory Tract Infection||5.8||8.0|
|1 Includes subjective complaints of fever.
2 Includes reported decreases in pulmonary function tests or decreased lung volume on chest radiograph associated with intercurrent illness or study drug administration.
Read the Tobi (tobramycin) Side Effects Center for a complete guide to possible side effects »
In clinical studies of TOBI® (tobramycin) , patients taking TOBI® (tobramycin) concomitantly with dornase alfa (PULMOZYME®, Genentech), ß-agonists, inhaled corticosteroids, other anti-pseudomonal antibiotics, or parenteral aminoglycosides demonstrated adverse experience profiles similar to the study population as a whole.
Concurrent and/or sequential use of TOBI® (tobramycin) with other drugs with neurotoxic or ototoxic potential should be avoided. Some diuretics can enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue. TOBI® (tobramycin) should not be administered concomitantly with ethacrynic acid, furosemide, urea, or mannitol.
Last reviewed on RxList: 11/21/2008
This monograph has been modified to include the generic and brand name in many instances.
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